TRAC-ER Intervention to Reduce Risky Alcohol Use and HIV Risk
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorUniversity of Kentucky
About this trial
Ecological momentary interventions (EMI), which use phones to deliver messages to reduce alcohol use and related risk behaviors during or prior to drinking events, can help to address triggers in real-time. GPS tracking can determine when individuals visit places they have previously reported drinking or triggers to drink and then EMI messages can be delivered upon arrival to prevent risky alcohol use. A mobile app has been developed that uses GPS tracking to determine when individuals visit "risky" places and then delivers a survey asking what behaviors they engaged in while at the location.
The goal of the proposed study is to use this app to enhance the Tracking and Reducing Alcohol Consumption (TRAC) intervention by delivering messages that encourage participants to employ strategies discussed during TRAC sessions when arriving at risky places. When they leave these places, they will complete a survey and breathalyzer reading in order to collect event-level self-report and biological data on alcohol use and HIV risk. If their breathalyzer result indicates alcohol use, they will receive harm reduction messaging. It is expected that combining TRAC with EMI ("TRAC-ER") will increase effectiveness by reinforcing topics discussed during these sessions, providing in-the-moment messaging to address triggers, and collecting real-time alcohol use data.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
is between the ages of 18-35 at the start of the study
owns a smartphone
has not been diagnosed with HIV
screens positively for at-risk alcohol use (score of 4 or higher on the AUDIT-C, OR report engaging in binge drinking at least once over the past 12 months).
Disqualifiers
do not speak English
are actively detoxifying from substances and need medical supervision
a score of 20 or greater on the Alcohol Use Disorders Identification Test
Trial design
Design model
Parallel
Treatments tested in this trial
Smartphone Based Alcohol Monitoring (SAM)
BehavioralSmartphone-based alcohol monitoring (SAM) using mobile breathalyzers and surveys.
Tracking and Reducing Alcohol Consumption (TRAC)
BehavioralThe TRAC intervention focuses on increasing motivation and building skills for avoiding triggers and managing situations that encourage drinking. It requires four 30-minute sessions with a counselor using videoconferencing and mobile phones. In addition to receiving the four sessions of intervention content, participants will complete smartphone-based self-monitoring of alcohol consumption, which will be discussed during intervention sessions.
TRAC-ER
BehavioralEcological momentary interventions (EMI) use phones to deliver messages to reduce alcohol use and related risk behaviors during or prior to drinking events. GPS tracking can determine when individuals visit places they have previously reported drinking or triggers to drink and then EMI messages can be delivered upon arrival to prevent risky alcohol use.
Treatment groups
405 Participants
are divided into 3 treatment groupsGroup A: SAM-Only Comparison GroupExperimental treatment 1 intervention
Group B: TRAC plus SAMExperimental treatment 2 interventions
Group C: TRAC-ER plus SAMExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Number of drinking days
Number of days in which alcohol was consumed based on breathalyzer readings greater than 0.00
Time frame
Measured daily for 30 day periods during months 1, 2, 3, 6, and 9Secondary outcomes
1
Number of binge drinking episodes
Number of binge drinking episodes (occasions when participants had 5+ drinks based on self-reported number of drinks)
Time frame
Measured daily for 30 day periods during months 1, 2, 3, 6, and 92
Number of drinks/drinking day
3 items: alcohol consumed (yes or no), number of drinks, and time spent drinking
Time frame
Measured daily for 30 day periods during months 1, 2, 3, 6, and 9Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Kentucky
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Yale University
Collaborator
Source ClinicalTrials.gov